A Study Manager job located in Whippany, NJ is currently available through Belcan. The overall objective of the Study Manager (STM) is to manage the planning, conduct, analysis and reporting of assigned global studies and complex local studies within the established timeframes and budget, with the quality and requirements necessary for global regulatory approvals.
Study Manager job duties:
* Identifies, implements, leads and manages a global, cross-functional Study Team for the duration of the study, working with functional line management to identify team members and resolve issues. Leads the yearly goal setting process for the study(ies) in scope in close collaboration with study team and all clinical team members * Supports protocol feasibility; leads the operational planning and tracking of the site feasibility * The STM manages all study related activities from an approved study concept to the final Clinical Study Report (CSR) to ensure study is conducted in high quality and within the given timeline and budget. * Provides operational input and insight into the preparation of the study protocol and contributes to other core study documents in close collaboration with the study team * Responsible for developing and tracking the total external study budget and accountable for providing monthly, quarterly and yearly estimates information to the Clinical Team and to Controlling. * Acts as Responsible Outsourcing Person in outsourced studies and manages the selection and oversight of external suppliers (e.g. CRO, Central Laboratory, Central Reading Center, etc.).
* Bachelor\"s degree * 7 years of relevant healthcare experience which including 3 years clinical operations in the pharmaceutical industry which includes direct monitoring and clinical trial/study management experience * In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Conference on Harmonization-ICH regulations) with a proven track-record leading the initiation and completion of clinical studies * Ability to successfully achieve results within a multi-cultural and geographically diverse team, and capability to create team culture and promote team spirit.
comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters
If you are interested in this Study Manager job in Whippany, NJ, please apply via the apply now link provided.
Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan engineers better outcomes through adaptive and integrated services - from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.